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A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Alzheimer's Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAGE-718
SAGE-718-matching Placebo
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring SAGE-718, Cognitive dysfunction, NMDA

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet the following criteria for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) at Screening: A memory complaint reported by the participant or their study partner A Clinical Dementia Rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5 Essentially preserved activities of daily living, in the opinion of the investigator Brain Magnetic Resonance Imaging (MRI) report, obtained within the 2 years preceding the Baseline Period, that is consistent with the diagnosis of AD with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment Have a score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening. Exclusion Criteria: Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have received study treatment in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the participant participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides (ASO) will be excluded Have a condition that precludes undergoing an MRI, in accordance with standard operating procedures at the imaging facility (eg, ferromagnetic metal in the body, claustrophobia), in a participant requiring MRI during Screening Have any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline Have a history, presence, and/or current evidence of Brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury Possible or probable cerebral amyloid angiopathy, according to the Boston Criteria Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities Seizures or epilepsy, with the exception of childhood febrile seizures Be at risk for suicidal ideation as per Columbia-Suicide Severity Rating Scale (C-SSRS) and/or in the opinion of the investigator Have any of the following medical conditions: Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator Supine vital signs outside of the following ranges during Screening (vital sign measurements may be repeated once if initial values exceed these ranges): i. Heart rate <50 or >100 bpm ii. Systolic blood pressure <100 or >160 mmHg iii. Diastolic blood pressure <60 or >100 mmHg Have a history, presence, and/or current evidence of serologic positive results for human immunodeficiency virus (HIV)-1 or HIV-2, or hepatitis B or C Have a positive pregnancy test, or be lactating, or intend to breastfeed during the study Is known to be allergic to any of SAGE-718 excipients, including soy lecithin

Sites / Locations

  • Sage Investigational SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAGE-718

Placebo

Arm Description

Participants will receive 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 [±2 days]), followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84.

Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.

Outcomes

Primary Outcome Measures

Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test
The WAIS-IV Coding Test is a valid and sensitive measure of cognitive dysfunction. Administration of the WAIS-IV Coding Test will use the traditional paper-and-pen format, in which the participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The score will be based on the total number of codes correctly completed over a 120-second time limit.

Secondary Outcome Measures

Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Number of Participants Who Withdraw Due to Adverse Events (AEs)

Full Information

First Posted
November 9, 2022
Last Updated
October 17, 2023
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05619692
Brief Title
A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Alzheimer's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia, Alzheimer's Disease
Keywords
SAGE-718, Cognitive dysfunction, NMDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAGE-718
Arm Type
Experimental
Arm Description
Participants will receive 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 [±2 days]), followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.
Intervention Type
Drug
Intervention Name(s)
SAGE-718
Intervention Description
Softgel lipid capsules.
Intervention Type
Drug
Intervention Name(s)
SAGE-718-matching Placebo
Intervention Description
Softgel lipid capsules.
Primary Outcome Measure Information:
Title
Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test
Description
The WAIS-IV Coding Test is a valid and sensitive measure of cognitive dysfunction. Administration of the WAIS-IV Coding Test will use the traditional paper-and-pen format, in which the participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The score will be based on the total number of codes correctly completed over a 120-second time limit.
Time Frame
Baseline to Day 84
Secondary Outcome Measure Information:
Title
Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity
Description
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Time Frame
From the inform consent signing up to end of the study (Up to approximately Day 116)
Title
Number of Participants Who Withdraw Due to Adverse Events (AEs)
Time Frame
From the inform consent signing up to end of the study (Up to approximately Day 116)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the following criteria for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) at Screening: A memory complaint reported by the participant or their study partner A Clinical Dementia Rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5 Essentially preserved activities of daily living, in the opinion of the investigator Brain Magnetic Resonance Imaging (MRI) report, obtained within the 2 years preceding the Baseline Period, that is consistent with the diagnosis of AD with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment Have a score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening. Exclusion Criteria: Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have received study treatment in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the participant participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides (ASO) will be excluded Have a condition that precludes undergoing an MRI, in accordance with standard operating procedures at the imaging facility (eg, ferromagnetic metal in the body, claustrophobia), in a participant requiring MRI during Screening Have any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline Have a history, presence, and/or current evidence of Brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury Possible or probable cerebral amyloid angiopathy, according to the Boston Criteria Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities Seizures or epilepsy, with the exception of childhood febrile seizures Be at risk for suicidal ideation as per Columbia-Suicide Severity Rating Scale (C-SSRS) and/or in the opinion of the investigator Have any of the following medical conditions: Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator Supine vital signs outside of the following ranges during Screening (vital sign measurements may be repeated once if initial values exceed these ranges): i. Heart rate <50 or >100 bpm ii. Systolic blood pressure <100 or >160 mmHg iii. Diastolic blood pressure <60 or >100 mmHg Have a history, presence, and/or current evidence of serologic positive results for human immunodeficiency virus (HIV)-1 or HIV-2, or hepatitis B or C Have a positive pregnancy test, or be lactating, or intend to breastfeed during the study Is known to be allergic to any of SAGE-718 excipients, including soy lecithin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Burmeister, MD
Phone
347-687-4985
Email
jan.burmeister@sagerx.com
Facility Information:
Facility Name
Sage Investigational Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Learn more about this trial

A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

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